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Drug Trials 'Snapshots' Could Get Photoshopped, CDER Says

 
• By Sue Sutter

Sponsors who disagree with how racial, gender and age-related demographic subgroup data for their products are described in public summaries may propose revisions and submit them for FDA consideration.

As FDA's Center for Drug Evaluation and Research continues to refine its Drug Trials Snapshots transparency program, it is inviting sponsors to propose their own edits to the publicly available summaries of demographic subgroup clinical trial data for recently approved products.

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